- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Bayer (Whippany, NJ)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Medical Affairs Women's Healthcare** The Director ... TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Medical Affairs Women's...contact information below. Bayer is an E-Verify Employer. **Location:** United States : Connecticut : Residence Based… more
- Bausch Health (Bridgewater, NJ)
- …international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek ... embody these values, come join our company and help us shape the future. We are all in it...drive our collective progress and impact. As a Senior Director in Health Economics and Outcomes Research (HEOR), you… more
- J&J Family of Companies (Raritan, NJ)
- … strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy, commercial and market access strategy, and ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …We are seeking a Medical Director , Migraine and Cluster Headaches, to join our US Medical Affairs team at Amneal Pharmaceuticals, Inc. The role serves as the ... state community. This role works with the Clinical Development, Clinical Operations, Regulatory Affairs , Program Management, and teams.* Interfaces with both… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director Clinical Development - Oncology Date: Dec 9, 2024 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 58170 ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… more
- J&J Family of Companies (Raritan, NJ)
- …and benefits information set forth in this posting applies to candidates hired in the United States . Candidates hired outside the United States will ... Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Oncology (Solid Tumor) to...Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US , the EU and… more
- Sanofi Group (Bridgewater, NJ)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... **Job Title:** Medical Director - Global Medical Evidence Generation **Location:** Cambridge, MA **About the Job** We are an innovative global healthcare company,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Director Clinical Development - Respiratory Date: Dec 17, 2024 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Associate Director Launch Excellence Date: Dec 23, 2024 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 59927 ... + **Cross-Functional Leadership** : Lead cross-functional teams, including marketing, sales, regulatory , and medical affairs , to ensure a coordinated approach… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** US Medical Director - Portfolio, New Products, Innovation- Vaccines **Location** : Bridgewater, NJ **About the Job:** The North American Medical ... real impact on millions of patients around the world. **Main Responsibilities:** The US Medical Director - New Products will provide medical and scientific… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** US Medical Director , Mainline Vaccines **Location** : Bridgewater, NJ / Morristown, NJ **About the Job** The North American Medical Team at Sanofi ... millions of patients around the world. **Main** **Responsibilities:** The US Medical Director , Mainline Vaccines, will contribute...information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …industry experience required + 4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience required + Experience ... pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience + Experience with ex-… more